NOVo-Helisen Depot HoUSe Dust Mites - A Prospective, Multicenter, Noninterventional Clinical Study on the Tolerability and Safety of Short One Strength UP-dosing in Children, Adolescents, and Adults in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 主要终点
- Safety of the One Strength dose escalation scheme in daily practice
研究概览
简要总结
The goal of this non-interventional study is to investigate the safety and tolerability of a new simplified up-dosing schedule for Novo-Helisen Depot.
Novo-Helisen Depot is an approved allergen immunotherapy used to treat allergies to house dust mites. For allergen immunotherapy, it is important that the allergen dose is gradually increased, a process known as up-dosing to induce immune tolerance to the allergen. The recently approved One Strength up-dosing scheme for Novo-Helisen Depot allows up-dosing with 6 injections instead of the previously required 14 injections.
The main questions the study aims to answer are:
How is the tolerability and the safety of One Strength up-dosing scheme in daily practice? This study includes approximately 105 patients (children (≥5 years), adolescents, and adults), receiving this treatment as part of their usual care.
Study data on safety and tolerability wil be collected for each patient during the first 8 injection visits.
The study will be conducted at 6-8 study sites in Poland.
详细描述
The Standard dose escalation scheme with the unmodified (native) SCIT house dust mite preparation Novo-Helisen Depot consists of 14 injections.
The newly approved One Strength dose escalation scheme, recently approved for children (≥5 years), adolescents (12-17 years) and adults (≥18 years), offers a simplified dose escalation scheme with only 6 injections. To date, the safety and tolerability of this One Strength escalation scheme has been demonstrated in 2 clinical trials involving 243 patients (aged 5-65 years). The objective of the present non-interventional study is to compare the safety and tolerability of the One Strength dose escalation scheme (6 injections) in different age groups (children, adolescents, adults) and to supplement available clinical trial data on safety and tolerability with clinical study data in daily practice.
Data collection during the first 8 visits of treatment with NHD (D.p./D.f.) using the One Strength dose escalation scheme:
Visit 1: Informed consent, In-/Exclusion-criteria, demographics, medical history, first injection (dose escalation)
Visits 2-6: 2nd to 6th injection (dose escalation)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from the patient. For patients under the age of 18, the consent of both parents/legal guardians is also required.
- •Patients who are eligible for treatment with the One Strength dose escalation scheme of NHD (D.p./D.f.) according to the specifications in the SmPC. These include children (5 to <12 years), adolescents (≥12 to <18 years) and adults (≥18 years) with allergic (IgE-mediated) diseases, such as allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma (see section 4 of the current SmPC)
- •The treatment decision must precede the decision to participate in the study and must be independent.
排除标准
- •Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.
结局指标
主要结局
Safety of the One Strength dose escalation scheme in daily practice
时间窗: up to study completion, approximately 11 to 20 weeks
* Number, incidence, type, intensity and time of occurrence of (serious) adverse events ((S)AEs) * Number, incidence, type, intensity and time of occurrence of (serious) adverse drug reactions ((S)ADRs) * Frequency and intensity of systemic allergic reactions * Proportion of patients who reach the maintenance dose without/with dose adjustment
Tolerability of the One Strength dose escalation scheme in daily practice
时间窗: up to study completion, approximately 11 to 20 weeks
Tolerability will be assessed by both the treating physicians and the patients using a 5-point Likert scale (Likert, 1932) with the following categories: "Very bad," "Bad," "Average," "Good," and "Very good".
次要结局
未报告次要终点